Vastuskiri

Dear Sir/Madam,

Please, note, there are upcoming changes in law from 1st January 2025.

Please, find below unofficial translation of the State Fees Act and the Tobacco Act.

1. 1. § 298⁴  of the State Fees Act stipulates –

(1) State fee of 5000 euros shall be paid before verification of the compliance of a notification of a tobacco product and a tobacco product related product (incl e-cigarettes).

(2) State fee of 740 euros shall be paid for amendment of the notification of a tobacco product and a tobacco product related product.

(3) State fee of 100 euros shall be paid annualy for the publication and maintaining of a notification of a tobacco product and a tobacco product related product.

2. 2. § 10⁴ of the Tobacco Act is amended, as follows

(3) On submission of a notification referred to in sections 10 to 10³ of this Act, the submitter shall pay the Health Board for the assessment of the information contained therein as follows:

(1) the fee for the assessment of one substance in e-liquid is 240 euros;

(2) the fee for the assessment of emissions in electronic cigarette and their refill pack is 965 euros.

 (4) On submission of a notification of the sales volumes of a tobacco product and a tobacco product related product, the notifier shall pay the Health Board a notification assessment fee of 240 euros.

The fee is for each ingredient in an e-liquid, including propylene glycol, glycerol, nicotine/nicotine salt, in addition to the flavourings used.

Please, note that only tobacco and menthol flavourings are allowed in Estonia according to the Tobacco Act:

§ 8¹.  Requirements for ingredients of electronic cigarettes

(2) The nicotine-containing and nicotine-free liquid shall not contain the following substances:

5) flavourings, except for the taste and smell of tobacco and menthol.

Answers for your questions:

1. 1. Please clarify your question "Do I have to pay for each different product with a different ECID, or do I only have to pay once for each company with the same Sender ID?". What do you mean „pay once for each company with the same Sender ID“?

Is there a payment for each product amendment and is it necessary to pay for adding the product presentation but not amending other product information?

According to § 298⁴ (2) of the State Fees Act, state fee of 740 euros shall be paid for each amendment (each modification) of the notification of a tobacco product and a tobacco product related product.

2. 2. The annual fee 100 euros is for all product of a submitter or each product?

According to § 298⁴ (3) of the State Fees Act, state fee of 100 euros shall be paid annualy for the publication and maintaining of a notification of a tobacco product and a tobacco product related product. It means this annual fee applies for each product.

3. 3. a) If one e-liquid have 6 substances in it, do this means that we need to pay 240*6=1440 euros for the assessment fee for this e-liquid?

Yes, you have understood correctly. According to § 10⁴ (3) of the Tobacco Act, the fee for the assessment of substance (ingredient) is per one substance (ingredient).

2. b. Do the opening pod system electronic cigarettes need to pay the fee for the evaluation of substances released ? Although there is no e-liquid when the opening pod system electronic cigarettes place into the market but when test we will use the e-liquid.

The fee for the assessment of emissions applies because it involves an assessment, although the pod system does not contain e-liquid.

3. c. If the sales volume of all products is 0, do we still need to pay the fee for the evaluation of the report?

Yes, the fee for the assessment of sales volume applies even if the sales volume is 0.

If you have any further questions about state fees and fees, please contact us again.

Kind regards,

Chemical Safety Department

Republic of Estonia Health Board

[email protected]

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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Dear Sir or Madam,

Hello. This is color from Shenzhen Smoore Technology Limited.

We know that starting from January 1, 2025,the e-cigarette product notification review and amendment , annually publication and storage of information ,  the assessment of the data all need pay the fee.

But we have some confusions about the payment.

1. 1. For the review and amendment of the notice, the submitter of the notice shall pay a state fee at the rate specified in the State Fees Act before submitting the notice.

A state fee of 5,000 euros is paid for the review of the notification of the e-cigarette product.---> Is there a payment for each product with different ECID or we just need each company with same submitter ID to pay once?

A state fee of 740 euros shall be paid for the amendment of the notification of the e-cigarette product. ---> Is there a payment for each product amendment and Is it necessary to pay for adding the product presentation but not amending other product information?

2. 2. For the publication and storage of the notice, the submitter of the notice shall pay a state fee at the rate specified in the State Fees Act by March 31 of each year at the latest.

A state fee of 100 euros is paid annually for the publication and storage of information on e-cigarette product. ---> The annual fee 100 euros is for all product of a submitter or each product ?

3. 3. the submitter of the notice shall pay the Health Board for the assessment of the data contained therein as follows:

1. a. the assessment fee for one substance in e-liquid is 240 euros; ---> if one e-liquid have 6 substances in it, do this means that we need to pay 240*6=1440 euros for the assessment fee for this e-liquid?

2. b. the fee for the evaluation of substances released from e-liquids of electronic cigarettes and their refill packs is 965 euros. --->Do the opening pod system electronic cigarettes need to pay the fee for the evaluation of substances released ? Although there is no e-liquid when the opening pod system electronic cigarettes place into the market but when test we will use the e-liquid.

3. c. When submitting a report on the sales volumes of the e-cigarette product, the submitter of the report shall pay the Health Board 240 euros for the evaluation of the report. ---> If the sales volume of all products is 0, do we still need to pay the fee for the evaluation of the report?

Thank you and looking forward to your reply.

Kind regards

Color

RDS Department

M:+86 15929921261

E: [email protected]

W: www.vaporesso.com